人工智能引导的血管检测以提升第三空间内镜手术安全性
人工智能引导下的解剖标志物检测以提升第三间隙内镜手术安全性
This prospective study aims to evaluate the performance of a novel Artificial Intelligence (AI) clinical decision support tool during third space endoscopic procedures, such as Endoscopic Submucosal Dissection (ESD) and Peroral Endoscopic Myotomy (POEM).
While these procedures are effective for treating gastrointestinal neoplasms and motility disorders, they carry risks of intraprocedural bleeding and perforation if submucosal blood vessels are not correctly identified and coagulated. Building on previous retrospective validation, this study will assess whether a real-time artificial intelligence model can assist endoscopists in detecting and delineating blood vessels more accurately and faster during live human procedures.
研究概览
详细说明
Background and Rationale
Third-space endoscopy procedures are technically demanding. The primary challenge lies in the inadvertent transection of submucosal vessels, which leads to bleeding that obscures the surgical field and increases the risk of perforation. Currently, vessel identification is entirely operator-dependent.
Our team has developed a deep-learning based artificial intelligence model trained on 250,000 annotated images from 150 POEM procedures. This model is optimized for minimal latency, allowing for real-time visual overlays (delineation) of blood vessels on the endoscopic monitor.
Study Objectives The primary objective is to evaluate the Vessel Detection Rate (VDR)-the proportion of vessels identified by the endoscopist when assisted by the AI compared to standard practice.
The study will also investigate:
Vessel Detection Time (VDT): The latency between a vessel appearing in the field of view and its identification.
Study Design & Workflow:
In this prospective study, the AI system will be integrated into the Olympus EVIS X1 series endoscopy stack. As the endoscopist navigates the submucosal space, the AI will provide real-time visual segmentation masks highlighting vessels. The performance will be recorded and compared against a post-procedure review by independent experts to calculate sensitivity and detection speed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Telangana
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Hyderabad、Telangana、印度、500032
- Asian Institute of Gastroenterology
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients diagnosed with Achalasia Cardia or neoplasms.
Exclusion Criteria:
- Patients with conditions deemed unsuitable for third space endoscopy procedures (e.g.: Candidiasis)
学习计划
研究是如何设计的?
设计细节
- 主要用途:设备可行性
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:With Artificial Intelligence
Endoscopist will see the AI generated segmentation mask |
Real time AI generated segmentation mask or delineation contours for sub-mucosal blood vessels visible on the endoscopy monitor. |
|
无干预:Without Artificial Intelligence
Endoscopist will not see the AI generated segmentation mask |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vessel Detection Rate (VDR)
大体时间:3 months
|
the proportion of vessels identified by the endoscopist |
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vessel Detection Time (VDT)
大体时间:3 months
|
The latency between a vessel appearing in the field of view and its identification. |
3 months
|
合作者和调查者
调查人员
- 首席研究员:Abhishek Tyagi、Asian Intitute of Gastroenterology
出版物和有用的链接
一般刊物
- Scheppach MW, Mendel R, Muzalyova A, Rauber D, Probst A, Nagl S, Rommele C, Yip HC, Lau LHS, Golder SK, Schmidt A, Kouladouros K, Abdelhafez M, Walter BM, Meinikheim M, Chiu PWY, Palm C, Messmann H, Ebigbo A. Use of artificial intelligence in submucosal vessel detection during third-space endoscopy. Endoscopy. 2025 Jul;57(7):760-766. doi: 10.1055/a-2534-1164. Epub 2025 Feb 5.
- Ebigbo A, Mendel R, Scheppach MW, Probst A, Shahidi N, Prinz F, Fleischmann C, Rommele C, Goelder SK, Braun G, Rauber D, Rueckert T, de Souza LA Jr, Papa J, Byrne M, Palm C, Messmann H. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec;71(12):2388-2390. doi: 10.1136/gutjnl-2021-326470. Epub 2022 Sep 15.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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